Hemostasis valve seal

Abstract

A seal for a hemostasis valve is provided as well as a novel seal stack for use in hemostasis valves. The seal stack includes a plurality of conical or frustoconical members including an anti-prolapse member, and a sealing member. The seal stack may optionally include a diaphragm and/or a second sealing member. The valve body may include a pressure sensing member which may be located in a sidearm.

Having thus described the invention, it is now claimed: 
     
       1. A seal for a hemostasis valve comprising,
 an anti-prolapse member comprising a rigid frustoconical structure having an annular base flange and a central through-hole; 
 a first sealing member comprising a flexible conical structure having an annular base flange, a blunted apex axially aligned with the through-hole of the anti-prolapse member, a seam oriented through the blunted apex of the first sealing member, a first registering structure at a first position on an upstream face of the base flange of the first sealing member, and a second registering structure complementary to the first registering structure of the first sealing member and positioned on a downstream face of the base flange of the first sealing member at an angular offset of φ relative to the first registering structure of the first sealing member, wherein φ is an angle between 10° and 90°, wherein an upstream face of the first sealing member receives a downstream face of the anti-prolapse member; and 
 a second sealing member comprising a flexible conical structure having an annular base flange, a blunted apex axially aligned with the through-hole of the anti-prolapse member, a seam oriented through the blunted apex of the second sealing member, a first registering structure at a first position on an upstream face of the base flange of the second sealing member, and a second registering structure complementary to the first registering structure of the second sealing member and positioned on a downstream face the base flange of the second sealing member at an angular offset of φ relative to the first registering structure of the second sealing member, wherein φ is an angle between 10° and 90°, wherein an upstream face of the second sealing member receives a downstream face of the first sealing member, and wherein the second sealing member is oriented at an angular offset of φ relative to the first sealing member. 
 
     
     
       2. The seal of  claim 1 , wherein φ is an angle between 10° and 20°, 20° and 30°, 30° and 40°, 40° and 50°, 50° and 60°, 60° and 70°, 70° and 80°, or 80° and 90°. 
     
     
       3. The seal of  claim 1 , further comprising a diaphragm, that is flexible and frustoconical, having an annular base flange and a central through-hole, wherein a downstream face of the diaphragm is received by an upstream face of the anti-prolapse member. 
     
     
       4. A seal for a hemostasis valve comprising:
 an anti-prolapse member comprising a rigid frustoconical structure having a conical wall, an annular base flange at a base of the conical wall of the anti-prolapse member, and a central through-hole in the conical wall of the anti-prolapse member; 
 a diaphragm, that is flexible and frustoconical, having a conical wall, an annular base flange at a base of the conical wall of the diaphragm, and a central through-hole in the conical wall of the diaphragm, wherein a downstream face of the conical wall of the diaphragm is received by an upstream face of the conical wall of the anti-prolapse member; and 
 a sealing member comprising a flexible conical structure having a conical wall, an annular base flange at a base of the conical wall of the sealing member, a blunted apex axially aligned with the through-hole of the anti-prolapse member and the through-hole of the diaphragm, a seam oriented through the blunted apex, wherein an upstream face of the conical wall of the sealing member receives a downstream face of the conical wall of the anti-prolapse member. 
 
     
     
       5. A hemostasis valve, comprising:
 a valve body comprising an inner luminal wall defining a lumen extending from an upstream opening to a downstream opening; 
 a seal stack comprising:
 an anti-prolapse member comprising a rigid frustoconical structure having a conical wall, an annular base flange at a base of the conical wall of the anti-prolapse member, and a central through-hole in the conical wall of the anti-prolapse member; 
 a sealing member comprising a flexible conical structure having a conical wall, an annular base flange at a base of the conical wall of the sealing member, a blunted apex axially aligned with the through-hole of the anti-prolapse member, a seam oriented through the blunted apex, wherein an upstream face of the conical wall of the sealing member receives a downstream face of the conical wall of the anti-prolapse member; 
 
 a mounting groove in the inner luminal wall sized to simultaneously receive the base flanges of the seal stack in a mounted relation; and 
 a frustoconical valve seat supportively receiving a downstream face of the seal stack, the frustoconical valve seat defining an orifice in fluid communication with the lumen of the valve body, wherein the blunted apex of the seal stack protrudes through the orifice. 
 
     
     
       6. The hemostasis valve of  claim 5 , wherein the inner luminal wall is an inner luminal wall of the valve body further comprising a pressure transducer in pressure communication with a lumen defined by the inner luminal wall of the valve body. 
     
     
       7. The hemostasis valve of  claim 5 , further comprising a diaphragm, that is flexible and frustoconical, having a conical wall, an annular base flange at a base of the conical wall of the diaphragm, and a central through-hole in the conical wall of the diaphragm, wherein a downstream face of the conical wall of the diaphragm is received by an upstream face of the conical wall of the anti-prolapse member. 
     
     
       8. The hemostasis valve of  claim 5 , further comprising a cylindrical seal disposed upstream of the seal stack, wherein a central through-hole of the cylindrical seal is aligned and in fluid communication with the lumen of the valve body. 
     
     
       9. The hemostasis valve of  claim 8 , further comprising a threaded compression fitting in axially compressive communication with the cylindrical seal such that compression of the cylindrical seal is controllable through turning the threaded compression fitting. 
     
     
       10. The hemostasis valve of  claim 9 , wherein the central through-hole of the cylindrical seal is sized to slidably receive a catheter in an uncompressed state, and to lockably receive a catheter in a compressed state. 
     
     
       11. The hemostasis valve of  claim 10 , further comprising a threaded mount for fixedly cooperating with cannulas. 
     
     
       12. The hemostasis valve of  claim 11 , further comprising a sidearm in communication with the lumen of the valve body downstream of the seal stack. 
     
     
       13. The hemostasis valve of  claim 12 , further comprising a pressure transducer in pressure communication with a lumen defined by the inner luminal wall of the sidearm.